Biostatistics, Outcomes Modeling, Clinical Design, and Administration

生物统计学、结果建模、临床设计和管理

基本信息

批准号：
7214976
负责人：
JEFFREY F WILLIAMSON
金额：
$ 24.29万
依托单位：
VIRGINIA COMMONWEALTH UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-12-01 至 2011-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7214976
关键词：
Accounting Advisory Committees Algorithms Anatomy Area Back Binomial Distribution Biometry Bladder Blood Vessels Brachytherapy Budgets Cancer Patient Caring Cell Survival Cervical Cervix Uteri Chi-Square Distribution Class Classification Clinical Clinical Data Clinical Research Clinical Trials Commit Communication Complex Complication Confidence Intervals Daily Data Data Analyses Data Set Development Diagnostic Dimensions Disorder by Site Dose Drug Formulations Elements End Point Ensure Evaluation Experimental Designs Face Facility Construction Funding Category Faculty Failure Feedback Figs - dietary Fractionation GDF15 gene Genetic Goals Hemorrhage Human Resources Image Imaging Phantoms In Vitro Individual Intensity-Modulated Radiotherapy Kolmogorov-Smirnov Test Label Leadership Literature Location Lung Malignant neoplasm of cervix uteri Malignant neoplasm of lung Malignant neoplasm of prostate Manuscripts Maps Measurement Measures Medical Medical Imaging Methodology Methods Modality Modeling Molecular Nitrogen Nodal Noise Non-Small-Cell Lung Carcinoma None or Not Applicable Normal Statistical Distribution Normal tissue morphology Numbers Operative Surgical Procedures Organ Outcome Outcome Study PLAB Protein Patients Pattern Pelvis Performance Physicians Physics Pneumonia Population Positioning Attribute Preparation Principal Component Analysis Probability Procedures Process Program Development Property Prostate Publishing Radiation Oncology Radiation therapy Radiobiology Range Rate Recipe Recording of previous events Rectum Regulation Relative (related person)Research Research Design Research Ethics Committees Research Personnel Residual state Risk Sample Size Sampling Scanning Score Series Services Side Significance Level Simulate Site Visit Source Staging Standards of Weights and Measures Statistical Methods Statistically Significant Structure Sum Techniques Technology Teflon Testing Time Toxic effect Uncertainty Upper arm Validation Value Meaning Variant Week Work base biomathematics cancer therapy clinical efficacy clinically significant data management day design desire experience fly human subject image processing image registration improved indexing interest lymph nodes neglect prescription document prescription procedure programs reconstruction rectal research study response simulation size time use treatment planning tumor vector vector control virtual

项目摘要

The overall goal of this Core is to provide administrative support, interproject communications, overall scientific leadership, and Core scientific services to all Projects and Cores to ensure that the scientific aims of Program Project are realized. Core Function 1 is to provide biostatistical and data management support to all Projects and Cores. The faculty biostatistician supported by the Core will contribute to detailed study design and hypothesis testing for all Projects and will support the specialized biomathematics needs of Projects 1-4 such as stochastic estimation and anatomy sampling. Core Function 2 is to develop bioeffective dose and theoretical outcome models for IGART plan evaluation and scoring outcomes of virtual clinical trials. The Core Leader will work with the Program's biomodelling consultant to select the most appropriate bioeffective dose, tumor control, and normal tissue response models and to identify appropriate model parameters and/or published outcome studies from which such parameters can be extracted. The Program biostatistician will provide guidance and support for model fitting procedures. These models will be used by Projects 2-4 and Core A to evaluate treatment plans, guide optimization, formulate clinical hypotheses, score virtual clinical trials, and to sum dose distributions with differing dose-time-fractionation patterns. Core Function 3 will be responsible for providing clinical guidance to all major scientific developments of this Program. An active Clinical Development Working Group, consisting of all clinical co- investigators along with Project and Core Leaders, will participate in the formulation of image guidance procedures, virtual clinical trials, and candidate processes for image-guided adaptive radiation therapy (IGART). A major task of this Core Function is to design intramural clinical trials using clinically-tested IGART technology to implement some form of dose escalation. In addition, Core Function 3 will provide clinical data management support for managing the accrual of human subjects to the Projects 3 and 4 clinical studies and to assure compliance with VCU IRB and federal regulations regarding the protection of human subjects. Core Function 4 is to provide administrative support, to promote inter-Project scientific communication, and to provide overall scientific direction to all Projects and Cores. The primary areas of administrative support include personnel and budget management, purchasing and manuscript preparation, and secretarial/clerical support. The Core will also provide a centralized communication matrix, including communication with NCI/NIH, connectivity and scientific communication among the different Projects and Cores, and integration of the External Advisory Board feedback into the PPG research plan execution. This will be achieved through required weekly Project/Core meetings, monthly meetings of all investigators, and annual face-to- face site visits with the External Advisory Committee Board.

该核心的总体目标是提供行政支持、项目间沟通、整体科学领导力，以及为所有项目和核心提供核心科学服务，以确保科学目标的计划项目已实现。核心功能1是提供生物统计和数据管理支持所有项目和核心。核心支持的生物统计学家将为详细研究做出贡献所有项目的设计和假设检验，并将支持专业生物数学的需求项目 1-4 例如随机估计和解剖采样。核心功能2是开发用于 IGART 计划评估和虚拟结果评分的生物有效剂量和理论结果模型临床试验。核心领导者将与该计划的生物建模顾问合作，选择最适当的生物有效剂量、肿瘤控制和正常组织反应模型，并确定适当的模型参数和/或已发表的结果研究，可以从中提取这些参数。这项目生物统计学家将为模型拟合程序提供指导和支持。这些模型将项目 2-4 和核心 A 用于评估治疗计划、指导优化、制定临床假设，对虚拟临床试验进行评分，并对不同剂量-时间-分割的剂量分布进行求和模式。核心功能3将负责为所有主要科学领域提供临床指导该计划的进展。一个活跃的临床开发工作组，由所有临床合作者组成研究人员与项目和核心领导者将参与图像指导的制定图像引导适应性放射治疗的程序、虚拟临床试验和候选流程（IGART）。该核心功能的主要任务是使用经过临床测试的 IGART 设计壁内临床试验实施某种形式的剂量递增的技术。此外，核心功能3将提供临床数据管理支持项目 3 和 4 临床研究的人类受试者的应计并确保遵守 VCU IRB 和有关保护人类受试者的联邦法规。核心职能 4 是提供行政支持，促进项目间科学交流，以及为所有项目和核心提供总体科学方向。行政支持的主要领域包括人事和预算管理、采购和稿件准备以及秘书/文书支持。该核心还将提供一个集中式通信矩阵，包括与 NCI/NIH，不同项目和核心之间的连接和科学交流以及集成外部顾问委员会对 PPG 研究计划执行的反馈。这将实现通过所需的每周项目/核心会议、所有研究人员的每月会议以及年度面对面会议接受外部咨询委员会的实地考察。